Adlai Nortye begins Phase I trial of AN4035

Adlai Nortye begins a global Phase I trial of AN4035 after FDA IND clearance, marking a key early clinical milestone in its RAS-targeted oncology pipeline.

Rhea-AI Filing Summary

Adlai Nortye Group Ltd. (ANL), a clinical-stage oncology company, reported that the first patient has been dosed with its antibody-drug conjugate AN4035 in Australia, initiating a global Phase I trial in patients with CEACAM5-enriched, RAS-addicted solid tumors.

The company also received a U.S. FDA “Study-May-Proceed” letter clearing its IND for AN4035, enabling expansion of the trial into the United States, and plans to file an additional IND for AN4035 with China’s NMPA. Adlai Nortye aims to report full Phase Ia data in the second half of 2027.

Key Terms

antibody-drug conjugate, pan-RAS(ON) inhibitor, CEACAM5-enriched, bystander-killing effect, +2 more

6 terms

antibody-drug conjugate medical

"AN4035 is a first-in-class ADC targeting CEACAM5"

An antibody-drug conjugate is a targeted medicine that combines an antibody, which can identify specific cells, with a powerful drug designed to destroy those cells. This approach allows for precise treatment, minimizing damage to healthy tissue. For investors, developments in this area can signal advances in cancer therapies and potential growth opportunities in the biotech sector.

pan-RAS(ON) inhibitor medical

"armed with a highly potent pan-RAS(ON) inhibitor payload"

A pan-RAS inhibitor is a drug designed to block the activity of the RAS family of proteins, which act like on/off switches controlling cell growth and survival. By targeting multiple RAS isoforms or mutation types at once, these medicines aim to stop signals that drive many cancers, so their trial results and approval potential can affect biotech valuations and the outlook for cancer-treatment pipelines much like a single key that can lock several similar doors at once.

CEACAM5-enriched medical

"global Phase I trial in patients with CEACAM5-enriched RAS-addicted solid tumors"

bystander-killing effect medical

"coupled with a potent bystander-killing effect"

investigational new drug (IND) regulatory

"on its investigational new drug (IND) application"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

Study-May-Proceed letter regulatory

"received a “Study-May-Proceed” letter from the U.S. Food and Drug Administration"

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Adlai Nortye (ANL) announce regarding its AN4035 program?

Adlai Nortye announced that the first patient has been dosed with AN4035 in Australia, initiating a global Phase I trial in CEACAM5-enriched, RAS-addicted solid tumors, and that it received a U.S. FDA “Study-May-Proceed” letter clearing its IND for this candidate.

What is AN4035 in Adlai Nortye (ANL)’s pipeline?

AN4035 is described as a first-in-class antibody-drug conjugate targeting CEACAM5 and armed with a pan-RAS(ON) inhibitor payload from the company’s RASiCA™ platform, designed for tumor-selective RAS pathway inhibition while aiming to spare normal tissues.

What is the scope of the new Phase I trial for AN4035 at Adlai Nortye (ANL)?

The global Phase I trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AN4035 as monotherapy and in combination with cetuximab in patients with CEACAM5-enriched, RAS-addicted solid tumors.

What regulatory progress did Adlai Nortye (ANL) report for AN4035?

Adlai Nortye reported receiving a U.S. FDA “Study-May-Proceed” letter for its AN4035 IND, clearing expansion of the trial into the United States, and stated it is also filing an IND application for AN4035 with China’s NMPA.

When does Adlai Nortye (ANL) expect to report AN4035 Phase Ia data?

Adlai Nortye stated that it remains on track to report full Phase Ia data for AN4035 in the second half of 2027, reflecting its development timeline for this global Phase I program.

How has AN4035 performed in preclinical studies according to Adlai Nortye (ANL)?

Adlai Nortye reports that in preclinical studies AN4035 showed favorable stability, nanomolar to picomolar cytotoxicity in CEACAM5-positive, RAS-addicted cell lines, a bystander-killing effect, and robust anti-tumor activity with deep tumor regression in CEACAM5-positive CDX and PDX models.

What are the main therapeutic areas in Adlai Nortye (ANL)’s pipeline?

Adlai Nortye highlights two key areas: precision RAS pathway targeted therapies, including oral pan-RAS(ON) inhibitor AN9025 and ADC AN4035, and next-generation PD-1/L1 pathway modulating immunotherapies, including AN8025, a multi-functional fusion protein.

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Available on EDGAR 09/08/2026 - 08:00 AM Accepted by SEC EDGAR 09/08/2026 - 08:00 AM Learn about SEC filing dates

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

under the Securities Exchange Act of 1934

For the month of September 2026

Commission File Number: 001-41773

Adlai Nortye Group Ltd. 

77 Robinson Road

#20-01, Robinson 77

Singapore 068896

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

☒ Form 20-F     ☐ Form 40-F

CONTENT

On September 8, 2026, Adlai Nortye Group Ltd. (previously known as Adlai Nortye Ltd.) (“Adlai Nortye” or the “Company”) issued a press release entitled “Adlai Nortye Announces First Patient Dosed in Australia and U.S. FDA IND Clearance for AN4035, a First-in-Class Pan-RAS(ON) Inhibitor-Based ADC”, a copy of the press release is attached to this Form 6-K as Exhibit 99.1.

Exhibits

Exhibit No.		Description
99.1		Press Release: Adlai Nortye Announces First Patient Dosed in Australia and U.S. FDA IND Clearance for AN4035, a First-in-Class Pan-PAS(ON) Inhibitor-Based ADC

1

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	Adlai Nortye Group Ltd.
	By:	/s/ Yang Lu
	Name:	Yang Lu
	Title:	Chief Executive Officer and Chairman of Board of Directors

Date: September 8, 2026 

2

Exhibit 99.1

Adlai Nortye Announces First Patient Dosed in Australia and U.S. FDA IND Clearance for AN4035, a First-in-Class Pan-RAS(ON) Inhibitor-Based ADC

First-in-class CEACAM5-targeting ADC armed with a pan-RAS(ON) inhibitor – designed for tumor-selective RAS pathway inhibition

First patient dosed in Australia; global Phase I initiated

U.S. FDA cleared IND with “Study-May-Proceed” letter

SINGAPORE and NORTH BRUNSWICK, N.J., September 8^th, 2026 (GLOBE NEWSWIRE) -- Adlai Nortye Group Ltd. (NASDAQ: ANL) (“Adlai Nortye” or the “Company”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, today announced that the first patient has been dosed with AN4035 in Australia, initiating the global Phase I trial in patients with CEACAM5-enriched RAS-addicted solid tumors. The Company also received a “Study-May-Proceed” letter from the U.S. Food and Drug Administration (FDA) on its investigational new drug (IND) application, clearing the path to expand the trial into the United States.

“AN4035 is the first proof-of-concept candidate from our RAS Inhibitor Conjugated Antibody (RASiCA™) platform, specifically engineered to address two pressing challenges in oncology. First, the ADC field urgently needs novel payload classes to overcome cross-resistance, as existing options remain largely confined to just topoisomerase I and microtubule inhibitors. Second, systemic pan-RAS(ON) inhibitors have been hampered by on-target, off-tumor toxicities, particularly in the skin and gastrointestinal tract. By conjugating our potent pan-RAS(ON) payload to a CEACAM5-targeting antibody, AN4035 is designed for tumor-selective delivery while sparing normal tissues,” said Dr. Archie Tse, President, Head of Research & Development. “Following regulatory clearance to begin the trial in Australia last month, we have dosed the first patient and secured a “Study-May-Proceed” letter from the U.S. FDA. We look forward to advancing this asset globally and remain on track to report full Phase Ia data in the second half of 2027.”

This global phase I trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AN4035 as monotherapy and in combination with cetuximab in patients with CEACAM5-enriched, RAS-addicted solid tumors. CEACAM5 is highly overexpressed in colorectal, pancreatic, and lung cancers – tumor types that frequently harbor RAS mutations. The Company is also filing an IND application for AN4035 with the China National Medical Products Administration (NMPA).

About AN4035

AN4035 is a first-in-class ADC targeting CEACAM5 and armed with a highly potent pan-RAS(ON) inhibitor payload. In preclinical studies, the ADC demonstrates favorable thermal and plasma stability with desirable pharmacokinetic properties. Strong intracellular payload retention drives nanomolar to picomolar cytotoxicity in CEACAM5-positive, RAS-addicted cancer cell lines, coupled with a potent bystander-killing effect. In vivo, AN4035 has shown robust anti-tumor activity with deep tumor regression in CEACAM5-positive CDX and PDX models. Compared with the payload alone, the ADC exhibits enhanced target-mediated tumor retention and significantly improved tumor selectivity over normal tissues, resulting in an overall favorable therapeutic index. Adlai Nortye is evaluating AN4035 in a global phase I trial in patients with CEACAM5-enriched RAS-addicted solid tumors.

About Adlai Nortye

Adlai Nortye is a global clinical-stage biopharmaceutical company dedicated to developing innovative cancer therapies. The global infrastructure supports the efficient execution of our robust pipeline of drug candidates covering two key therapeutic areas:

1) Precision RAS pathway targeted therapies: including the oral pan-RAS(ON) inhibitor AN9025, and the CEACAM5-targeting ADC AN4035 engineered from the Company’s proprietary RASiCA™ (RAS Inhibitor Conjugated Antibody) platform, which efficiently delivers a potent pan-RAS(ON) inhibitor to the tumor site.

2) Next-generation PD-1/L1 pathway modulating immunotherapies: including AN8025, a multi-functional fusion protein that simultaneously modulates T cells and antigen-presenting cells.   

Forward-Looking and Cautionary Statements

This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “potential,” “continue,” “ongoing,” “targets” and similar statements. Among other things, statements that are not historical facts, including statements about the Company’s beliefs and expectations, the business outlook and quotations from management in this announcement, as well as the Company’s strategic and operational plans, are or contain forward-looking statements.

The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”), in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Forward-looking statements involve inherent risks and uncertainties. Factors that could cause the Company’s actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of the Company’s preclinical studies, clinical trials and other therapeutic candidate development efforts; the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; whether the clinical trial results will be predictive of real-world results; the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of the Company’s therapeutic candidates; the Company’s ability to establish, manage, and maintain corporate collaborations, as well as the ability of its collaborators to execute on their development and commercialization plans; the implementation of the Company’s business model and strategic plans for its business and therapeutic candidates; the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of the Company’s expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing; risks related to changes in healthcare laws, rules and regulations in the PRC and United States or elsewhere. Further information regarding these and other risks is included in the Company’s filings with the SEC. All information provided in this press release and in the attachments is as of the date of this press release, and the Company does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

Contacts:
Investor Relations:
ir@adlainortye.com

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 PRESS RELEASE: ADLAI NORTYE ANNOUNCES FIRST PATIENT DOSED IN AUSTRALIA AND U.S. 12.0 KB